Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04231695
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2019-12-28
Brief Title:
Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit
Sponsor:
Hospital Jose Maria Cullen
Organization:
Hospital Jose Maria Cullen
Study Overview
Official Title:
Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Goals Primary compare changes in norepinephrine requirements before and after hemoperfusion HP treatment
Secondary demonstrate the decrease in levels of IL-6 assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT SOFA establish the resolution of shock clearance of lactate and mortality at discharge from INTENSIVE CARE UNIT ICU at 30 and 60 days
Secondary demonstrate the decrease in levels of IL-6 assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT SOFA establish the resolution of shock clearance of lactate and mortality at discharge from INTENSIVE CARE UNIT ICU at 30 and 60 days
Detailed Description:
The study will take place at UTI Dr José María Cullen Hospital in the city of Santa Fe An observational study will be carried out in adult patients with septic shock according to the definition of Sepsis-3 presenting hypotension requiring vasopressors to maintain a mean arterial pressure MAP of 65 mmHg blood lactate 2 mmol L after adequate resuscitation with fluids and in need of extracorporeal membrane oxygenation Extracorporeal Membrane Oxygenation ECMO Renal Replacement Therapy TRR which may be continuous Continuous Renal Replacement Therapy CRRT or Extended Slow Daily Dialysis SLEDD or both added to the hemoperfusion HP treatment
The study was designed by the authors without receiving any input from companies
Patients will be treated according to The Surviving Sepsis Campaign 2016 recommendations identification and control of the infectious focus surgery It will begin with antibiotics as soon as possible resuscitation with crystalloids at 30 mL kg in case of hypotension and continue according to assessment of dynamic and static parameters EV 1000 Swan Ganz central venous pressure and echocardiography used at the discretion of attending physician Noradrenaline will be administered to maintain a MAP 65 mmHg Dobutamine will be indicated if the minute volume 30 L min m2 According to our practice adrenaline will be added if the dose of norepinephrine exceeds 2 μg kg min In addition 100 mg of hydrocortisone will be administered every 8 hours
In case of requiring TRR for AKI continuous vein-venous hemodiafiltration will be started using Prismaflex or Amplya equipment with a dose of 35 mL kg h at a 1 1 ratio the replacement solution dialysate solution with AN ST 15 filter HF 14 or HFT 14 or 17 or 22 with citrate as an anticoagulation method In the case of ECMO anticoagulation will be performed with heparin according to the standardized practice of the service
Treatment with HA 330 cartridges Hemoperfusion treatment will be initiated as soon as possible no later than 12 hours after the diagnosis of septic shock An 8-hour treatment will be indicated for 2 two consecutive days Prior to using the cartridge 12500 units of sodium heparin will be placed inside through the hole located in the upper region During the next 30 minutes it will be necessary to rotate it so that heparin is distributed throughout its interior After 30 minutes a physiological solution should be washed a total of 2000 mL with an infusion pump or by gravity pump in order to remove the heparin and in turn avoid the formation of bubbles or air accumulation After this step it is ready to be used either for isolated HP therapies or in association with other therapies SLEDD ECMO CRRT
Data collection For each patient who enters the protocol a record will be completed with the data from the sampling date and time of extraction with the results of IL-6 and PCT and with the clinical data The latter will be
age
sex
preexisting diseases
infectious focus
community or acquired sepsis
positive crops
SOFA score daily for 7 seven days
APACHE II upon admission and before starting HP treatment
IL-6 as admission criteria and before and after each treatment
procalcitonin PCT on admission and on days 5-7
lactate before and after treatment with HP and daily for 7 seven days
additional laboratory blood count hepatogram urea creatinine coagulogram norepinephrine adrenaline IDI dose
antibiotic dosing according to the established sampling scheme
administered volume of fluids daily for 7 seven days
requirement of TRR and ECMO
Informed consent will be obtained for each patient who enters the protocol for participation Samples will be taken at predetermined times for 48-72 hours following the established procedure
The study was designed by the authors without receiving any input from companies
Patients will be treated according to The Surviving Sepsis Campaign 2016 recommendations identification and control of the infectious focus surgery It will begin with antibiotics as soon as possible resuscitation with crystalloids at 30 mL kg in case of hypotension and continue according to assessment of dynamic and static parameters EV 1000 Swan Ganz central venous pressure and echocardiography used at the discretion of attending physician Noradrenaline will be administered to maintain a MAP 65 mmHg Dobutamine will be indicated if the minute volume 30 L min m2 According to our practice adrenaline will be added if the dose of norepinephrine exceeds 2 μg kg min In addition 100 mg of hydrocortisone will be administered every 8 hours
In case of requiring TRR for AKI continuous vein-venous hemodiafiltration will be started using Prismaflex or Amplya equipment with a dose of 35 mL kg h at a 1 1 ratio the replacement solution dialysate solution with AN ST 15 filter HF 14 or HFT 14 or 17 or 22 with citrate as an anticoagulation method In the case of ECMO anticoagulation will be performed with heparin according to the standardized practice of the service
Treatment with HA 330 cartridges Hemoperfusion treatment will be initiated as soon as possible no later than 12 hours after the diagnosis of septic shock An 8-hour treatment will be indicated for 2 two consecutive days Prior to using the cartridge 12500 units of sodium heparin will be placed inside through the hole located in the upper region During the next 30 minutes it will be necessary to rotate it so that heparin is distributed throughout its interior After 30 minutes a physiological solution should be washed a total of 2000 mL with an infusion pump or by gravity pump in order to remove the heparin and in turn avoid the formation of bubbles or air accumulation After this step it is ready to be used either for isolated HP therapies or in association with other therapies SLEDD ECMO CRRT
Data collection For each patient who enters the protocol a record will be completed with the data from the sampling date and time of extraction with the results of IL-6 and PCT and with the clinical data The latter will be
age
sex
preexisting diseases
infectious focus
community or acquired sepsis
positive crops
SOFA score daily for 7 seven days
APACHE II upon admission and before starting HP treatment
IL-6 as admission criteria and before and after each treatment
procalcitonin PCT on admission and on days 5-7
lactate before and after treatment with HP and daily for 7 seven days
additional laboratory blood count hepatogram urea creatinine coagulogram norepinephrine adrenaline IDI dose
antibiotic dosing according to the established sampling scheme
administered volume of fluids daily for 7 seven days
requirement of TRR and ECMO
Informed consent will be obtained for each patient who enters the protocol for participation Samples will be taken at predetermined times for 48-72 hours following the established procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None